510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN070004Unknown

Xpert Ev, Model Gxev-100N-10; Genexpert Dx System, Models P/n 900-0144, 900-0145, 900-0146, 900-0065

Cepheid, Sunnyvale CA / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN070004 is the FDA 510(k) clearance record for XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065, a class II device, cleared for Cepheid on under FDA product code OAI (Assay, Enterovirus Nucleic Acid). FDA's definition for product code OAI reads: "Consists of primers, probes, enzymes and controls for the amplification and detection of enterovirus RNA in cerebrospinal fluid (CSF) from individuals who have signs and symptoms consistent with meningitis or meningoencephalitis. The...". FDA records list 62 510(k) clearances for Cepheid, from to . As of , FDA records show no recalls naming DEN070004.

Clearance record

Decision date
Received
(4 days to decision)
Product code
OAI Assay, Enterovirus Nucleic Acid
Regulation
21 CFR 866.3225
Device class
Class II
Review panel
Microbiology
Applicant
Cepheid 904 Caribbean Dr., Sunnyvale CA
Third party review
No

Clearances, product code OAI

Trailing 12 months

FDA records hold no clearances under product code OAI in the trailing twelve months.

FDA records show no clearances under product code OAI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OAI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260